Identity
- Trade Name
- Protective Film EUDAMED
- Device Name
- Medical dressing roll EUDAMED
- Model / Reference
- HAP0510 EUDAMEDHAP1010 EUDAMEDHAP1510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942273349384 EUDAMED06942273349407 EUDAMED06942273349421 EUDAMED
- Basic UDI-DI
- 69593857MDR000001CB EUDAMED
- EMDN Code
- M04010202 POLYURETHANE FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Protective Film by Zhende Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69593857MDR000001CB | Class I | Active |
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Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED afe61779-a9f9-496c-9c13-dc2a803c0fbc 61 fields · synced Jul 12, 2026
- EUDAMED d9bcc421-3a75-4dc8-945d-06fac9998ab4 61 fields · synced May 17, 2026
- EUDAMED 556cff46-21b3-4ded-ad5f-07340b09e61b 61 fields · synced May 18, 2026